# China NMPA Product Recall - X-ray computed tomography equipment

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-china-investment-co-ltd/17991e5a-27d9-44ee-b4d0-f0e358a2271f/
Source feed: China

> China NMPA product recall for X-ray computed tomography equipment by Philips (China) Investment Co., Ltd. published August 11, 2017. Recall level: Level 3 Recall. Philips (China) Investment Co., Ltd. initiated a voluntary Level III recall of its X-ray Computed To

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. voluntarily recalls X-ray computed tomography equipment.
- Company Name: Philips (China) Investment Co., Ltd.
- Publication Date: 2017-08-11
- Product Name: X-ray computed tomography equipment
- Recall Level: Level 3 Recall
- Recall Reason: The product in question has a software issue that may cause unexpected radiation and unclear images.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips (China) Investment Co., Ltd.
- Summary: Philips (China) Investment Co., Ltd. initiated a voluntary Level III recall of its X-ray Computed Tomography Equipment, as announced by the National Medical Products Administration (NMPA) on August 11, 2017. The recall addresses critical software problems identified in the affected devices. These issues could potentially result in unexpected patient radiation exposure and the production of unclear images, impacting both patient safety and diagnostic accuracy. This action falls under the regulatory oversight of the NMPA, which governs medical device registration and import in China, as indicated by the referenced National Medical Device Registration Certificate and Import Certificate. While specific inspection dates were not detailed, the company's decision to conduct a voluntary recall underscores its commitment to product safety and regulatory compliance. Philips is taking required actions to address these deficiencies, and further specifics regarding affected product models, specifications, and batches are available in an associated recall event report form.

Company: https://www.globalkeysolutions.net/companies/philips-china-investment-co-ltd/65759337-23bf-4cad-9163-71c3b842aa8b/